Biohaven Ltd.: Too Far, Too Fast (Downgrade) (NYSE:BHVN)

The saddest line in Of Mice and Men is “It could have been.”” – Kurt Vonnegut.

It’s been exactly a year since I last looked. Biohaven Co., Ltd.New York Stock Exchange: BHVN). have stocks There have been huge rallies in recent months. Considering it’s been 12 months since my last post. article It is time to follow up on this promising biopharmaceutical. Here’s the updated analysis:

Company Overview:

Biohaven Ltd. was spun off from the original Biohaven shortly before Pfizer acquired Biohaven in October 2022. This biopharmaceutical focus is focused on developing therapeutics across multiple platforms leveraging Biohaven’s neuropharmacology expertise. The company is headquartered in the British Virgin Islands and has headquarters in New Haven, Connecticut. The stock is currently trading north of $33.00 per share, making approx. Market capitalization: $2.7 billion.

The company has a large and diverse pipeline of novel therapies for people suffering from neurological and neuropsychiatric disorders, rare diseases and other strategic treatment-relevant conditions. It is important to note that many of the Company’s numerous drug candidates are in early stages. Biohaven’s full pipeline can be accessed by clicking: here.

Recent developments:

After Biohaven, the stock price fell about 20% at the end of July. presentation The FDA has declined to approve an NDA for troriluzole, an investigational treatment targeting the movement disorder spinocerebellar ataxia (SCA). Although the company considered the data from the Phase 3 study compelling, the FDA noted that the trial did not reach its primary endpoint.

Specifically, Biohaven plans to complete enrollment in early 2024 for two randomized, double-blind, placebo-controlled Phase 3 studies of troriluzole for obsessive-compulsive disorder, or OCD.

The company also has a late-stage compound called BHV-7000 targeting multiple indications. The company plans to initiate pivotal clinical trials focusing on BHV-7000 for patients with focal epilepsy by the end of this year and for patients with bipolar disorder in the first half of 2024.

Biohaven is also developing a compound called BHV-8000. The company is initiating a Phase 2/3 study of BHV-8000 targeting Parkinson’s disease. The study should begin in 2024.

Finally, in September, Biohaven completed enrollment in ‘RESILIENT’, a pivotal Phase 3 study designed to evaluate the efficacy and safety of the compound taldefgrobep alfa as an adjuvant therapy to improve muscle mass and function in patients with spinal muscular atrophy (SMA). . Treated with standard treatment.

But it was data from a very early-stage candidate called BHV-1300 that sparked the recent stock rally. In late September, Biohaven revealed that BHV-1300 can reduce IgG by more than 90% after repeated administration. Although these data are indeed impressive and could potentially imply deeper IgG reduction compared to existing standard FcRn targeted therapies, BHV-1300 is in the early stages of development. This data was also obtained through testing on cynomolgus monkeys. The company plans to submit an IND or investigational new drug application for BH-1300 by the end of this year.

Analyst commentary and balance sheet:

After the third quarter results were released, five analyst firms, including JPMorgan and Piper Sandler, reissued/assigned a buy opinion on the stock. The proposed price target range is $31 to $37 per share.

Approximately 10% of outstanding shares are currently underheld. Insiders, including the company’s CEO and CFO, have purchased about $25 million worth of shares since August at prices ranging from $18.44 to $22.57 per share. This was the only insider activity in the stock so far in 2023.

As of October 5, the company had $495 million worth of cash and marketable securities on its balance sheet. 2nd offer Early October after the end of the third quarter. The company had a net loss of $102.6 in the third quarter. result This one was posted on November 14th.

verdict:

Biohaven certainly has a lot to offer.“Shoot at goal” Within the pipeline, several of them are targeting potentially lucrative end markets. The pipeline should deliver several testing milestones in 2024 as well. However, commercialization of Biohaven is still several years away. Additionally, based on its current quarterly burn rate, the company will likely raise capital again sometime in 2024.

In addition, the stock price has risen significantly recently, putting the stock price in the middle of the current target price range. I made money on Biohaven. cover call These are holdings expiring in 2023 in current money. But I’m not chasing the stock’s recent rally, which saw the stock more than double in the second half of 2023. If the stock price falls back to the range where insiders have been buying recently ($18.50-$22.50 per share), then I’ll probably take on a new position at BHVN at that point.

I had a hard time for a long time, not knowing the value of what I had thrown away and avoiding the memories of what I had thrown away..”—Charles Dickens, Great Expectations.